Coronary Crossing System in Patients With Coronary Chronic Total Occlusions (NCT05813704) | Clinical Trial Compass
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Coronary Crossing System in Patients With Coronary Chronic Total Occlusions
China156 participantsStarted 2023-11-07
Plain-language summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years and older.
. Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located.
. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
. There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
. Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
. Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months.
. The target CTO occluded segment length ≥ 5 mm (visual inspection).
. Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Acute myocardial infarction within 30 days prior to baseline procedure.
. Life expectancy \< 1 year.
. Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
. The target CTO has an iatrogenic dissection that occurred within the past 3 months.
. Left ventricular ejection fraction less than 35%.
. Severe aortic or mitral valve disease.
. Planned left ventricular (LV) support device during CTO PCI.
. Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.